WORLD OF MEDICINE A127, Instructions For Use Manual

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General Information
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3 General Information
3.1 Description of the Device
The device itself is non-invasive and designed for use in non-sterile areas. It pumps
medically sterile irrigation fluids through a sterile tube. These fluids are used to dis-
tend and irrigate corresponding body cavities to provide space and improve visibil-
ity for the attending physician. The device can be used with electrolyte-free media
(e.g., glycine 1.5 % or sorbitol 3.0 %) and with isotonic, electrolyte-containing me-
dia (e.g., saline 0.9 % or Ringer's lactate). The device functions only with the tube
sets described in the accessory list (see Chapter Accessory List [
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48]).
During arthroscopic procedures the device can be operated at nominal flow rates
of up to 1.5 l/min and a maximum pressure of 150 mmHg can be selected.
The device operates with a completely non-contact pressure measurement of the
irrigation medium. The contact-free pressure measurement is achieved by integrat-
ing the pressure membrane into the tube set. The pressure membrane transfers
the tube pressure to the electronics of the device via a pressure sensor. The pres-
sure control circuit continuously compares the actual pressure with the nominal
pressure. The function of the device is to maintain the nominal pressure.
3.2 Intended Use and Contraindications
3.2.1 Intended Use
WARNING!
Use only with necessary training
The device is intended to be used only by surgeons and support personnel with the
necessary training in arthroscopic procedures.
The product A127 is an irrigation pump for diagnostic and/or surgical arthroscopic
procedures. Such procedures may include:
• Ligament injuries
• Meniscus injures
• Cartilage injures
• Operating planning and re-examination
The irrigation pump serves to distend and irrigate joints in the knee, shoulder, hip
and elbow, as well the wrist and ankle joint.
The user can select the desired joint pressure.
The pump attempts to reach and maintain the preset pressure in the joint by sup-
plying irrigation fluid. If the joint cannot be drained (e.g., because closed valve at
instrument), and if the pre-selected pressure has been reached, the pump reduces
the inflow of the fluid and attempts to maintain the preset pressure. If the intraar-
ticular pressure falls below the selected value, fluid automatically continues to be
supplied.
The device is used in the non-sterile area of a lit or darkened operating room and
can be attached with a toggle bolt to the rear side of the device on a tripod, or can
be set up in an equipment rack as well. The positioning should be at the height of
the joint to be irrigate.
Patient population There are no restrictions to consider specifically concerning the patient population.
Recommended pressure The nominal pressure can be preset to between 5 and 150 mmHg. The preset pres-
sure should be based on the average blood pressure of the patient to prevent
bleeding in the joint. The manufacturer recommends the following pressure set-
tings for the following application areas:
Knee joint 50 mmHg
Shoulder joint 50 mmHg
Hip joint 60 mmHg
Elbow joint 30 mmHg
Ankle joint 70 mmHg
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